HOW MIGHT YOU DEFY IMAGINATION?
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Senior Manager (Process Development) in Singapore.
Senior Manager (Process Development)
What you will do
The successful candidate will apply subject matter expertise to support technology transfer and ongoing cGMP production of commercial protein biologics processes. Scope of work could include:
• Lead site PD activities for continuous improvement, productivity improvement, and product life cycle management.
• Lead and manage PD safety and compliance initiatives including inspection readiness.
• Manage and oversee PD related projects, ensuring they are completed on time, within scope, and budget. Analyze project outcomes to identify areas for improvement and drive continuous optimization.
• Represent PD on key projects or business processes.Stay abreast of industry trends and leverage expertise to ensure the success of the Amgen Singapore Site, focusing on reliability, efficiency, agility, and differentiation.
• Collaborate with cross-functional teams and network drug substance teams for process alignment by applying advanced technical principles and concepts.
• Site PD champion for digital literacy and new digital tools deployment for process monitoring, tech transfer, and facility modeling. Apply best practices to leverage data for more proactive and predictive approaches.
• Support regulatory filings, audits and inspections, and other CMC activities.
Win
What we expect of you
Basic Qualifications
· Doctorate Degree and 2 years of biologics process development or commercial-scale technical support experience Or
· Master’s Degree and 6 years of biologics process development or commercial-scale technical support experience Or
· Bachelor’s Degree and 8 years of biologics process development or commercial-scale technical support experience
Preferred Qualifications
· 6+ years in a technical role supporting manufacturing processes or 8+ years as a project manager for cross-functional teams within regulated environments (i.e., cGMP)
· Strong oral and verbal communication skills, interact effectively with diverse internal and external (suppliers) stakeholders.
· Knowledgeable in regulatory filings authoring and inspections. Experienced in biopharma product end to end lifecycle management (e.g product team lead).
· Familiarity in MoF single use facility operational aspects of commercial biopharma manufacturing and proficient in big data analysis.
· Working experience with capital / engineering project from early stage to project turnover.
· Stakeholder Communication: Maintain clear and effective communication with all project stakeholders in multicultural working environment, including providing regular updates and managing expectations.
· Agility and Learning: Promote a culture of agility and learning within project teams, encouraging innovation and adaptability in a dynamic business environment.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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